An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools
Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis
treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.
Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly
immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM.
Determination of number of doses will be based on physician qualitative assessment at weeks
4 and 8.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE.
16 weeks, 20 weeks or 24 weeks
No
Michael Gold
Principal Investigator
GoldSkin Care
United States: Food and Drug Administration
IST-US-064-04-AME
NCT00168753
July 2004
March 2005
Name | Location |
---|---|
Nashua Dermatology | Nashua, New Hampshire 03062 |
Dermatology Associates Of Knoxville | Knoxville, Tennessee 37917 |
Monheit Dermatology Associates | Birmingham, Alabama 35203 |
Bayshore Dermatology | Fairhope, Alabama 36532 |
Jayne Fortson | Anchorage, Alaska 99501 |
Bakersfield Dermatology & Skin Cancer Medical Group | Bakersfield, California 93301 |
Integrated Research Group | Riverside, California 92501 |
Robert Greenberg | San Ramon, California 94582 |
Front Dermatology | Denver, Colorado 80014 |
Skin and Cancer Associates | Tamarac, Florida 33309 |
Michael Scannon | Tampa, Florida 33602 |
Atlanta Derm, Vein & Research Center | Alpharetta, Georgia 30004 |
Pearlridge Dermatology | Aiea, Hawaii 96701 |
Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
Calumet Dermatology Associates | Calumet City, Illinois 60477 |
Michael Greenberg | Elk Grove Village, Illinois 60007 |
David J. Coynik | Peru, Illinois 61354 |
Melissa Knuckles | Corbin, Kentucky 40701 |
Richard Eisen | Plymouth, Massachusetts 02360 |
Psoriasis Treatment Center | Grand Rapids, Michigan 49503 |
Woodson Clinical Studies Group, Inc. | Las Vegas, Nevada 89101 |
Jerry Bagel | East Windsor, New Jersey 08512 |
Catskill Dermatology | Monticello, New York 12701 |
Marina I Peredo | Smithtown, New York 11787 |
Buffalo Medical Group | Williamsville, New York 14221 |
Wilmington Health Associates Dermatology | Wilmington, North Carolina 28401 |
Robert Brodell | Warren, Ohio 44481 |
Dermatology & Laser Center of Roseberg | Roseburg, Oregon 97470 |
Dermatology Assoc of Plymouth Meeting | Plymouth Meeting, Pennsylvania 19462 |
Gold Skin Care | Nashville, Tennessee 37201 |
Bellaire Dermatology Associates | Bellaire, Texas 77401 |
Texas Dermatology Research | Dallas, Texas 75201 |
Mark Wallis | Longview, Texas 75601 |
Stephen Miller | San Antonio, Texas 78201 |
Stephen Flax | Winchester, Virginia 22601 |
Dermatology & Laser Center | Bellingham, Washington 98225 |